Avoid routine daily use of fluoxetine for depression after stroke, recommends JAMA study
Australia: A recent study in the journal JAMA Neurology has found that the routine daily use of 20 mg of fluoxetine did not affect the prevalence of clinically significant symptoms of depression during the first 6 months after a stroke. The results from the AFFINITY trial suggest that patients with recent stroke should not be treated routinely with 20 mg daily of fluoxetine hydrochloride to treat or prevent depression symptoms during the first six months after the stroke.
Generally, the prevalence of clinically significant symptoms of depression decreases steadily during the first 6 months after a stroke associated with minimal to moderate neurologic deficits and the study showed that fluoxetine use did not affect that decrease.
During the first year after a stroke, 1 in every 3 people is affected by depression. However, the evidence supporting the use of antidepressants in this population is scant. To fill this knowledge gap, Osvaldo P. Almeida, University of Western Australia, Perth, Western Australia, Australia, and colleagues aimed to investigate whether daily treatment with 20 mg of fluoxetine hydrochloride reduces the proportion of people affected by clinically significant symptoms of depression after stroke.
For this purpose, the researchers conducted a secondary analysis of the Assessment of Fluoxetine in Stroke Recovery parallel-group, randomized (1:1 assignment), double-blind, placebo-controlled clinical trial. They recruited 1221 participants in Australia, New Zealand, and Vietnam between January 11, 2013, and June 30, 2019, and were followed up for 6 months. Adults aged 18 years or older were recruited 2 to 15 days after experiencing a stroke associated with modified Rankin Scale score of 1 or higher.
A total of 607 participants (378 men [62.3%]; mean age, 64.3 years) were randomly assigned treatment with placebo, and 614 participants (397 men [64.7%]; mean age, 63.4 years) were randomly assigned treatment with 20 mg of fluoxetine hydrochloride daily for 26 weeks. The groups were balanced for demographic and clinical measures.
At baseline, 112 patients (18.5%) in the placebo group and 116 patients (18.9%) in the fluoxetine group had PHQ-9 scores of 9 or higher.
A prespecified secondary outcome of the trial was a 9-item Patient Health Questionnaire (PHQ-9) score of 9 or lower was. Assessments were completed at baseline and at 4, 12, and 26 weeks.
Key findings of the study include:
- During follow-up, 126 of 596 participants (21.1%) treated with placebo and 121 of 598 participants (20.2%) treated with fluoxetine had PHQ-9 scores of 9 or higher.
- A similar proportion of participants with PHQ-9 scores less than 9 at baseline who were treated with fluoxetine hydrochloride and placebo developed PHQ-9 scores of 9 or higher during the trial (placebo, 14.8%; and fluoxetine, 13.0%).
- A slightly higher number of participants in the placebo group than in the fluoxetine group had a participant-reported clinician diagnosis of depression (7.0% vs 4.3%).
- By week 26, 14 participants (2.3%) in the placebo group and 12 participants (1.9%) in the fluoxetine group had died.
The researchers concluded, "Routine daily treatment with 20 mg of fluoxetine did not decrease the proportion of people affected by clinically significant symptoms of depression after a stroke, nor did it affect the proportion of people prescribed an antidepressant or receiving nonpharmacologic treatments compared with placebo."
Almeida OP, Hankey GJ, Ford A, et al. Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery: The AFFINITY Randomized Clinical Trial. JAMA Neurol. 2021;78(9):1072–1079. doi:10.1001/jamaneurol.2021.2418